FLOW DETECTOR

Description of Event or Problem

REPORT OF "FREE FLOW' OF NITROGLYCERIN RECEIVED. THE PUMP WAS BEING SET UP IN THE EMERGENCY DEPARTMENT TO ADMINISTER A NITROGLYCERIN INFUSION AT 3 ML/HR. AT INITIAL SETUP, A NURSE IMMEDIATELY NOTED A FAST FLOW OF FLUID IN THE DRIP CHAMBER. SHE STOPPED THE FLOW, TURNED THE DEVICE OFF/ON, RESET IT FOR 3 ML/HR AND RESTARTED THE INFUSION. THE SAME SCENARIO OCCURRED. THE DEVICE DID NOT ALARM, BUT THE NURSE REPORTED SHE IMMEDIATELY INTERVENED AND MAY NOT HAVE GIVEN THE PUMP TIME TO ALARM. THE PT EXPERIENCED A DROP IN BLOOD PRESSURE FROM A BASELINE OF 120-140/70 TO 66/30. SHE WAS PLACED IN THE TRENDELENBERG POSITION AND HER BLOOD PRESSURE QUICKLY RETURNED TO BASELINE. THE PUMP WAS SWITCHED OUT AND THE SAME TUBING WORKED FINE IN THE NEW DEVICE. THE PT WAS THEN TRANSFERRED TO THE ICU. UPON ARRIVAL IN THE ICU, THE DEVICE WAS ALARMING FOR "FLOW." THE ICU NURSE NOTED THAT THE NITROGLYCERIN WAS FLOWING TOO FAST. THE PT REPORTEDLY HAD ANOTHER TRANSIENT DROP IN BLOOD PRESSURE, BUT QUICKLY RECOVERED AFTER THE INFUSION WAS STOPPED. THE TUBING WAS SWITCHED OUT, AND THE NEW SET WAS THEN USED SUCCESSFULLY WITH THE SECOND PUMP THAT WAS INITIATED IN THE ER. THERE WERE NO ADVERSE SEQUELAE REPORTED.

Additional Manufacturer Narrative

TESTING AND INVESTIGATION CONFIRMED FREE FLOW WITH A RETURNED SET. THE RETURNED UNUSED SET TESTED OK. THE FLOW DETECTOR TESTED OK. THE PUMP WAS RECEIVED WITH LOOSE BOARDS, HOWEVER, WHEN TESTED WITH A NEW SET THE UNIT PASSED ALL PERFORMANCE VERIFICATION AND LONG TERM TESTS WITHIN PRODUCT SPECIFICATION. A DEFECTIVE ADMINISTRATION SET CAUSED THE FREE FLOW.